Key Takeaways

  • VTI reported 1.06 D less myopic progression and 0.58 mm less axial elongation with NaturalVue Multifocal 1 Day compared with a virtual control group over 3 years
  • The PROTECT trial included children aged 7 to younger than 13 years and evaluated refractive and axial-length outcomes associated with pediatric myopia progression
  • VTI reported that 59% of treated children averaged no more than 0.25 D of progression per year and 55% demonstrated axial growth within the study's emmetropic benchmark

Visioneering Technologies (VTI) announced completed 3-year results from the PROTECT clinical trial evaluating NaturalVue (etafilcon A) Multifocal 1 Day contact lenses for slowing myopia progression in children.

Ashley Tuan, OD, MS, PhD, chief medical officer at VTI, is scheduled to present the full findings at the American Academy of Optometry annual meeting in Anaheim, California.

PROTECT was designed as a prospective, double-masked, multinational randomized controlled trial evaluating the safety and effectiveness of NaturalVue Multifocal 1 Day for pediatric myopia management.

According to results reported by VTI, children wearing the lens demonstrated 1.06 D less myopic progression compared with a virtual control group over 3 years (95% CI, 0.86-1.25; P < .001). The company also reported 0.58 mm less axial elongation (95% CI, −0.66 to −0.49; P < .001).

The findings address both refractive error and axial length, key measures used to assess myopia progression.

With completion of PROTECT, VTI said NaturalVue Multifocal 1 Day is the first soft contact lens using a catenary power curve design to demonstrate more than 1 D less myopic progression than a control group over 3 years, according to VTI.

Dr. Tuan noted that the trial demonstrated both a refractive treatment effect and significant slowing of axial elongation.

“We see a large refractive treatment effect together with significant slowing of axial elongation to the expected level for emmetropic children of these ages and ethnicities, providing a more complete picture of NaturalVue's performance in children with myopia,” she said.

VTI pointed to previously published research suggesting that each additional diopter of myopia is associated with increasing risks of myopia-related ocular complications. Research cited by the company indicates that reducing myopia progression by 1 D is associated with an approximately 40% reduction in the likelihood of developing myopic maculopathy and an approximately 23% reduction in retinal detachment risk, independent of a specific myopia-control intervention.

“Every diopter matters, which is why the magnitude of the completed PROTECT clinical trial results is important,” said Brett O'Connor, OD, FAAO, of Smith Eye Associates in Ponte Vedra, Florida.

“NaturalVue Multifocal 1 Day demonstrated 1.06 D less myopic refractive progression versus control at 3 years, along with a 0.58 mm reduction in axial elongation versus control,” Dr. O'Connor said. “For eye care professionals managing pediatric progressive myopia, the amount of progression you can reduce matters for the long term.”

The company also reported that 59% of children wearing NaturalVue Multifocal 1 Day progressed by no more than 0.25 D per year on average, a threshold commonly used to characterize nonprogressive myopia.

Additionally, 55% of children had axial growth within the emmetropic benchmark used in the study. VTI said average axial growth trends across all age groups evaluated remained within published ranges for emmetropic eye growth.

PROTECT, or the PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial, was conducted at sites in the United States, Canada, Hong Kong and Singapore. The per-protocol cohort included 102 children aged 7 to younger than 13 years with baseline refractive error ranging from −0.75 D to −5.00 D. Analyses were adjusted for age, sex, ethnicity, country, study site and baseline refractive value.